Clinical Trials Logo
  1. Home
  2. Pancreatic Neoplasms
  3. NCT02920944
  4. Details
NCT02920944 Clinical Trial

Diagnostic Yield of 20-gauge Procore Needle for EUS-guided FNA Biopsy in Solid Pancreatic Lesions

Pancreatic Neoplasms Clinical Trial

Official title:
Technical Feasibility and Diagnostic Yield of New 20-gauge Procore Needle for EUS-guided FNA Biopsy in Solid Pancreatic Lesions; Comparison With 22-gauge Procore Needle

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02920944
Other study ID # EUS 20 gauge
Secondary ID
Status Completed
Phase N/A
First received September 28, 2016
Last updated October 2, 2017
Start date July 2016
Est. completion date October 2017

Study information
Verified date October 2017
Source Seoul St. Mary's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to examine technical feasibility and diagnostic yield of new 20-gauge Procore needle for EUS-guided fine needle biopsy in solid lesions by comparing with 22-gauge Procore needle. The study design is prospective, randomized study.

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date October 2017
Est. primary completion date October 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Patients older than 20 years referred to our medical center for EUS-FNB with diagnosed or suspected solid pancreatic masses according to clinical evaluation and imaging studies.

Exclusion Criteria:

- cystic pancreatic lesions, patients haemodynamically unstable or with severe coagulopathy (international normalized ratio [INR] > 1.5 or platelet count < 50,000 cells/cubic millimeter [cmm3]), patients unable to suspend anticoagulant/anti-platelet therapy, pregnancy, inability or refusal to give informed consent, and refusal to participate in the study.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• EUS-FNB with 20 gauge ProCore needle
EUS-FNB with 20-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland)
• EUS-FNB with 22 gauge ProCore needle
EUS-FNB with 22-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland)

Locations
Country Name City State
Korea, Republic of The Catholic University of Korea Seoul No State

Sponsors (2)
Lead Sponsor Collaborator
Seung Bae Yoon Seoul St. Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary single diagnostic yield of the histologic core up to 5 minutes after endoscopic ultrasound-guided fine needle biopsy
Secondary total diagnostic yield of the histologic core up to 5 minutes after endoscopic ultrasound-guided fine needle biopsy
See also
  Status Clinical Trial Phase
Recruiting NCT04085055 - Fine Needle Biopsy of Solid Pancreatic Mass Lesions N/A
Recruiting NCT01950572 - Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Terminated NCT00529113 - Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic Cancer Phase 1
Recruiting NCT05351983 - Patient-derived Organoids Drug Screen in Pancreatic Cancer N/A
Recruiting NCT04809935 - EUS-Coeliac Plexus Block Versus Radiofrequency Ablation in Pain Relief of Patients With Malignancy Phase 4
Recruiting NCT05481476 - Surufatinib Combined With Sintilimab and AG in First-line Therapy of Patients With Locally Advanced or Metastatic Pancreatic Cancer Phase 2
Not yet recruiting NCT04652271 - International Pancreatic Surgery Outcomes Study - PancreasGroup.Org
Active, not recruiting NCT02950064 - A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations Phase 1
Completed NCT03054987 - Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography for Malignant Distal Biliary Obstruction N/A
Completed NCT02909530 - Comparison Between Olympus EZ Shot 3Plus 19G and EZ Shot 2 19G in EUS-guided FNB of Solid Pancreatic Masses N/A
Completed NCT02374411 - Knowledge, Attitudes, and Practice of Surgeons Toward Nutrition Support in HIPEC Patients N/A
Completed NCT01770405 - Clinical Registry of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract N/A
Terminated NCT01313416 - Gemcitabine and CT-011 for Resected Pancreatic Cancer Phase 2
Terminated NCT01515046 - Clinical Trial of High-dose Vitamin C for Advanced Pancreatic Cancer Phase 2
Enrolling by invitation NCT01465425 - Extracolonic Findings on Computed Tomography (CT) Colonography
Terminated NCT01434459 - Study of Gemcitabine With TheraSphere® (Yttrium-90)in Patients With Hepatic Tumors of Pancreatobiliary Origin Phase 1
Completed NCT00985777 - Vitamin E δ-Tocotrienol Administered to Subjects With Resectable Pancreatic Exocrine Neoplasia Phase 1
Completed NCT00385177 - Phase 1 Dose Escalation Study of SN2310 Injectable Emulsion in Patients With Advanced Solid Tumors Phase 1
Recruiting NCT00178763 - Hyperthermia With Chemotherapy for Locally Advanced or Metastatic Pancreas Cancer Phase 2
Completed NCT00196105 - Malignant Obstruction ZILVER Against Routine Therapy (MOZART I) N/A